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Randomized controlled clinical trial of intermittent theta-burst stimulation (iTBS) combined with motor image-based brain computer Interface (MI-BCI) to improve lower limb motor function in patients with ischemic stroke

Randomized controlled clinical trial of intermittent theta-burst stimulation (iTBS) combined with motor image-based brain computer Interface (MI-BCI) to improve lower limb motor function in patients with ischemic stroke

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093863
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-09-02
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

experimental group:iTBS combined with MI-BCI intervention training
control group A:sham iTBS combined with MI-BCI intervention training
control group B:iTBS combined with lower limb motomed intervention training

Sponsors

Department of Rehabilitation,Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) In accordance with the "Diagnostic criteria for Cerebrovascular Diseases" formulated by the Fourth Academic Conference on Cerebrovascular Disease of the Chinese Medical Association, and diagnosed as unilateral cerebral hemispheric ischaemic stroke confirmed by cranial CT or MRI; (2) First-ever onset of the disease, with no previous history of stroke, aged 30-75 years old, and 2 weeks-6 months after the onset of the disease; (3) Mini-mental Status Examination (MMSE): 21-27 points; (4) Brunnstrom Hemiplegia Motor Function Assessment >= stage I; (5) Patients' vital signs were stable, without obvious communication and comprehension disorders, and able to cooperate in completing the treatment and assessment; (6) Patients signed the informed consent form by themselves or authorised a delegate to sign the form.

Exclusion criteria

Exclusion criteria: (1) with pacemakers, metal objects, metal implants, cochlear implants, and hearing assistive devices; (2) with a history of previous cranial surgery and severe cranial defects that interfere with the wearing of the EEG cap; (3) with increased intracranial pressure; (4) with a history of epilepsy and a family history of epilepsy; (5) with severe organic diseases such as combined cardiac, hepatic, and renal disorders; (6) with significant aphasia, hearing impairment, and visual field impaired; (7) undergoing other central neuromodulation training; (8) pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment Lower Extremity;

Secondary

MeasureTime frame
Montreal Cognitive Assessment;functional ambulation category scale;Functional near-infrared spectroscopy;resting-stating EEG;

Countries

China

Contacts

Public ContactWen Wu

Zhujiang Hospital of Southern Medical University

wuwen66@163.com+86 136 1142 7189

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026